Trial · NCT02848443
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of S95005 when given in combination with oxaliplatin | up to 4 weeks after the first treatment administration | |
| Primary | Dose Limiting Toxicity (DLT) of S95005 when given in combination with oxaliplatin | up to 4 weeks after the first treatment administration | |
| Primary | Number of participants with adverse events as a measure of safety and tolerability for S95005-oxaliplatin. | through study completion, an average of 9 months | Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 |
| Primary | Changes in standard hematology as a measure of safety and tolerability for S95005-oxaliplatin | through study completion, an average of 9 months | |
| Primary | Changes in biochemistry as a measure of safety and tolerability for S95005-oxaliplatin | through study completion, an average of 9 months | |
| Primary | Changes in coagulation as a measure of safety and tolerability for S95005-oxaliplatin | through study completion, an average of 9 months | |
| Primary | Changes in urinalysis as a measure of safety and tolerability for S95005-oxaliplatin | through study completion, an average of 9 months | |
| Primary | Changes in vital signs as a measure of safety for S95005-oxaliplatin | through study completion, an average of 9 months | Vital sign measurements will include temperature, systolic and diastolic blood pressure, heart rate, and respiratory rate. |
| Primary | Changes in ECOG (Eastern Cooperative Oncology Group) performance status as a measure of safety and tolerability for S95005-oxaliplatin | through study completion, an average of 9 months | |
| Secondary | Antitumor activity assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and CEA (Carcinoembryonic Antigen) | through study completion, an average of 9 months | |
| Secondary | Number of participants with adverse events as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 |
| Secondary | Changes in standard hematology as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | |
| Secondary | Changes in biochemistry as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | |
| Secondary | Changes in coagulation as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab. | through study completion, an average of 9 months | |
| Secondary | Changes in urinalysis as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | |
| Secondary | Changes in vital signs as a measure of safety for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | Vital sign measurements will include temperature, systolic and diastolic blood pressure, heart rate, and respiratory rate. |
| Secondary | Changes in ECOG (Eastern Cooperative Oncology Group) performance status as a measure of safety and tolerability for S95005-oxaliplatin + bevacizumab or nivolumab. | through study completion, an average of 9 months | |
| Secondary | PDL-1 expression, tumour-infiltrating CD8 T cell density, for S95005-oxaliplatin + nivolumab | up to 8 weeks after the first treatment administration | Tumour biopsy at baseline and at the end of Cycle 4 |
| Other | Circulating protein biomarkers analysis | through study completion, an average of 9 months | Samples collected at C1D1 (day 1 of cycle 1) and at withdrawal will be subjected to proteomic analysis for identification of potential predictive and resistance biomarkers for S 95005 and/or oxaliplatin response or biological activity. |
| Other | Circulating tumour DNA analysis | day 1 of cycle 1 (each cycle is 28 days) | Samples collected at C1D1 will be subjected to genomic analysis to study mutations currently observed in colorectal cancer |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02848443/registered